Transmyocardial revascularization system and method of use

ABSTRACT

A transmyocardial revascularization system including a plurality of inserts formed of a material to elicit a healing response in tissue of the myocardium and deployment instruments and associated components for deploying the inserts into the wall of the myocardium. The inserts are arranged to be disposed within respective lumens or channels in the wall of the myocardium. The inserts can take various forms, e.g., be solid members, tubular members, or porous members, and may be resorbable, partially resorbable or non-resorbable. In some embodiments the inserts are arranged to be left in place within the channels in the wall of the myocardium to result in plural lumens which enable blood to flow therethrough and into contiguous capillaries. The deployment instruments are arranged to pierce the tissue of the myocardium from either the endocardium or the epicardium to insert the inserts into the myocardium, depending on the particular deployment instrument used. The deployment instruments may make use of a stabilizing device to stabilize them during the procedure of inserting the inserts into the myocardium. A controller may also be provided as part of the system to coordinate the operation of the deployment instrument with the cardiac cycle. The formation of the lumens can be achieved either by the inserts or by some other means, such as a piercing tip or an energy applicator forming a portion of the instrument. The inserts may include one or more of pharmaceuticals, biologically active agents, radiopaque materials, etc.

RELATED APPLICATIONS

[0001] This application is a Divisional of our earlier filed U.S. patentapplication, Ser. No. 09/773,855, filed on Feb. 1, 2001, entitledTransmyocardial Revascularization System And Method Of Use, which is inturn a Continuation of our earlier filed U.S. patent application, Ser.No. 09/369,107, filed on Aug. 5, 1999 entitled TransmyocardialRevascularization And Method Of Use, now U.S. Pat. No. 6,203,556, whichin turn is a Continuation of our earlier filed U.S. patent application,Ser. No. 09/958,788, filed on Oct. 29, 1997, entitled TransmyocardialRevascularization System, now U.S. Pat. No. 5,980,548, all of whosedisclosures are incorporated by reference herein, and which are assignedto the same assignee as the subject invention.

BACKGROUND OF THE INVENTION

[0002] This invention relates generally to medical systems andprocedures and more particularly to systems and procedures for effectingrevascularization of the myocardium of a living being.

[0003] Atherosclerosis is the leading causes of death in the industrialworld today. During the disease process, atherosclerotic plaques developat various locations within the arterial system of those affected. Theseplaques restrict the flow of blood through the affected vessels. Ofparticular concern is when these plaques develop within the bloodvessels that feed the muscles of the heart. In healthy hearts, cardiacblood perfusion results from the two coronary arterial vessels, the leftand right coronary arteries which perfuse the myocardium from theepicardial surface inward towards the endocardium. The blood flowsthrough the capillary system into the coronary veins and into the rightatrium via the coronary sinus. When atherosclerosis occurs within thearteries of the heart it leads to myocardial infarctions, or heartattacks, and ischemia due to reduced blood flow to the heart muscle.

[0004] Over the past few years numerous methods for treatingcardiovascular disease have become available. Traditional methodsutilize open surgical procedures to access the heart and bypassblockages in the coronary blood vessels. In these procedures, thepatient's heart is surgically exposed and one or more coronary arteriesare replaced/bypassed with synthetic or natural bypass grafts. Duringconventional cardiac surgery, the heart is stopped using cardioplegiasolutions and the patient is put on cardiopulmonary bypass which uses aheart-lung machine to maintain circulation throughout the body duringthe surgical procedure. A state of hypothermia is induced in the hearttissue during the bypass procedure to preserve the tissue from necrosis.Once the procedure is complete, the heart is resuscitated and thepatient is removed from bypass. There are great risks associated withthese surgical procedures such as significant pain, extendedrehabilitation times, and high risk of mortality for the patient. Theprocedure is time-consuming and costly to perform. This surgery alsorequires that the patient have both adequate lung and kidney function inorder to tolerate the circulatory bypass associated with the procedureand a number of patients which are medically unstable are thus not acandidate for bypass surgery. As a result, over the past few yearsminimally invasive techniques for performing bypass surgery have beendeveloped and in some instances the need for cardiopulmonary bypass andextended recovery times are avoided. In addition, as an alternative tosurgical methods, non-surgical procedures, such as percutaneoustransluminal coronary angioplasty, rotational atherectomy, and stentinghave been successfully used to treat this disease in a less invasivenon-surgical fashion.

[0005] In balloon angioplasty a long, thin catheter containing a tinyinflatable balloon at its distal end is threaded through thecardiovascular system until the balloon is located at the location ofthe narrowed blood vessel. The balloon is then inflated to compress theobstructing plaque against the arterial wall, thereby restoring orimproving the flow of blood to the local and distal tissues. Rotationalatherectomy utilizes a similarly long and thin catheter, but with arotational cutting tip at its distal end for cutting through theoccluding material. Stenting utilizes a balloon tipped catheter toexpand a small coil-spring-like scaffold at the site of the blockage tohold the blood vessel open. While many patients are successfullyrelieved of their symptoms and pain, in a significant number ofpatients, the blood vessels eventually reocclude within a relativelyshort period of time. In addition, for a large number of patients thatare in the later stages of ischemic heart disease, the currenttechnology offers little hope for long term cure. In these patients evenextending the patient's life for several months provides a significantbenefit to the patients and their families.

[0006] Although these non-surgical procedures are much less costly andless traumatic to the patient than coronary bypass surgery there are anumber of patients for which these procedures are not suitable. Forcertain types of patients the presence of extremely diffuse stenoticlesions and total occlusion in tortuous vessels prohibits them frombeing candidates. In addition to these procedures which attempt toreopen or bypass the coronary vessels, direct myocardialrevascularization has been performed by inducing the creation of newchannels, other than the coronary arteries themselves, to supplyoxygenated blood and remove waste products from the heart tissue.Myocardial revascularization is a technique used to supplement the bloodsupply delivered to the heart by providing the ischemic inner surface ofthe heart, known as the endocardium, with direct access to the bloodwithin the ventricular chamber. Typically the endocardium receives itsnutrient blood supply entirely from the coronary arteries that branchthrough the heart wall from the outer surface known as the epicardium.

[0007] In an article entitled “New Concepts In Revascularization OfMyocardium” by Mirhoseini et al. in Ann. Thor. Surg., 45:415-420, April,1988 the work of investigators exploring several different approachesfor direct revascularization of ischemic myocardium is discussed. Onerevascularization technique utilizes “myoepexy”, which consists ofroughening of the myocardial surface to enhance capillarization. Anothertechnique, known as “omentopexy”, consists of sewing the omentum overthe heart to provide a new blood supply. Another approach involvesimplanting the left internal mammary artery directly into heart muscleso that blood flowing through the side branches of the artery willperfuse the muscle.

[0008] Similar revascularization techniques have involved the use ofpolyethylene tubes, endocardial incisions, and the creation ofperforated or bored channels with various types of needles, and needleacupuncture. For example, T-shaped tubes have been implanted in themuscle, with the leg of the T-tube extending into the ventricular cavityas reported by Massimo et al. in an article entitled “MyocardialRevascularization By A New Method Of Carrying Blood Directly From TheLeft Ventricular Cavity Into The Coronary Circulation” appearing in J.Thorac. Surg., 34:257-264, August, 1957. In an article entitled“Experimental Method For Producing A Collageral Circulation To The HeartDirectly From The Left Ventricle” by Goldman et al. in the journal ofThoracic and Cardiovascular Surgery, 31:364-374, March, 1965, severalexperimental methods for myocardial revascularization are described. Onemethod involved the implantation of excised perforated carotid arteriesinto the left ventricular wall. Goldman et al. also examined the use ofimplanted perforated polyethylene tubing in a similar fashion.

[0009] Needle acupuncture approaches to direct myocardialrevascularization have been made and were based upon the premise thatthe heart of reptiles achieve myocardial perfusion via small channelsbetween the left ventricle and the coronary arterial tree as describedby Sen et al. in their article entitled “Transmyocardial Acupuncture: ANew Approach To Myocardial Revascularization” in the Journal of Thoracicand Cardiovascular Surgery, 50:181-187, August, 1965. In that article itwas reported that researchers attempted to duplicate the reptiliananatomy to provide for better perfusion in human myocardium byperforating portions of the ventricular myocardium with 1.2 mm diameterneedles in 20 locations per square centimeter. It has been shown thatthe perfusion channels formed by mechanical methods such as acupuncturegenerally close within two or three months due to fibrosis and scaring.As a result these types of mechanical approaches have been abandoned infavor of the use of lasers to effect the transmyocardialrevascularization (TMR).

[0010] U.S. Pat. No. 5,591,159 (Taheri) describes a device for effectingmyocardial perfusion that utilizes slit needles to perforate themyocardium. The needles may also utilize a laser beam directed throughthe lumens of the needles. The device uses a trans-femoral approach toposition the device into the left ventricle of the patient. A plunger isactivated to cause the needles to enter the myocardium several times.Perforation of the myocardium may be effected by means of a laser beamthrough the lumen of the needle or high velocity drill.

[0011] U.S. Pat. No. 5,655,548 (Nelson et al.) describes a method forperfusing the myocardium using a conduit disposed between the leftventricle and the coronary sinus. In one method, an opening is formedbetween the left ventricle and the coronary sinus, and the coronaryostium is partially occluded using a stent that prevents the pressure inthe coronary sinus from exceeding a predetermined value. Blood ejectedfrom the left ventricle enters the coronary sinus during cardiacsystole. The apparatus limits the peak pressure in the coronary sinus tominimize edema of the venous system. The system utilizes retroperfusionvia the coronary sinus of the venous system.

[0012] Previous researchers had explored long term retroperfusion viathe coronary sinus but found that its leads to edema of the cardiacveins which are incapable of sustaining long-term pressures above about60 mm Hg. The procedure basically places a stent-like plug in the leftventricle so that blood flows into the coronary sinus and then into themyocardium via the venous system using retroperfusion, not into themyocardium directly. In the aforementioned Nelson et al. patent there isdisclosed the use of a cutting instrument, such as a cannulated needle,a rotating blade, or medical laser to provide the required opening forthe conduit. It is believed that when implanted in the heart, the plugand stent will result in long-term retrograde perfusion of themyocardium using the cardiac venous system and will cause aredistribution of the flow within the venous system so that a greaterfraction of the deoxygenated blood will exit through the lymphatic stemand the Thebesian veins. The inventors also describe the use of aconduit which takes the place of the coronary sinus.

[0013] U.S. Pat. No. 4,658,817 (Hardy) describes a surgical carbondioxide laser with a hollow needle mounted on the forward end of thehandpiece. The needle is used to perforate a portion of the tissue, forinstance the epicardium, to provide the laser beam direct access todistal tissue of the endocardium for lasering and vaporization. Thedevice does not vaporize the tissue of the outer wall instead itseparates the tissue which recoils to its native position after theneedle's removal. This technique eliminates surface bleeding and theneed for suturing the epicardium as is done with other techniques.

[0014] In U.S. Pat. No. 5,607,421 (Jeevanandam) discloses that laserchannels remain open because carbonization associated with the laserenergy inhibits lymphocyte, macrophage, and fibroblast migration. Thus,in contrast to channels created by needle acupuncture, laser channelsheal more slowly and with less scar formation which allowsendothelialization and long term patency.

[0015] It has been reported by Moosdorf et al. in their article entitled“Transmyocardial Laser Revascularization—Morphologic PathophysiologicAnd Historical Principles Of Indirect Revascularization Of The HeartMuscle” in Z Kardiol, 86(3): 147-164, March, 1997 that thetransmyocardial laser revascularization results in a relevant reductionof clinical symptoms such as angina and an increase of exercise capacityin approximately two thirds of the patients treated. Objective data ofenhance myocardial perfusion as assessed by positron emissiontomography, thallium scans, and stress echocardiography has also beenpresented in other studies. Some researchers have found that TMRchannels created by CO2 lasers are surrounded by a zone of necrosis withan extent of about 500 microns. In heart patients who died in the earlypostoperative period (1 to 7 days) almost all channels were closed byfibrin clots, erythrocytes, and macrophages. At 150 days post procedure,they observed a string of cicatricial tissue admixed with a polymorphousblood-filled capillary network and small veins, which very rarely hadcontinuous links to the left ventricular cavity. At the 2 week postprocedure point a granular tissue with high macrophage and monocyteactivity was observable. See for example, the article by Krabatsch etal. entitled “Histological Findings After Transmyocardial LaserRevascularization” appearing in J. Card. Surg. 11:326-331, 1996, and thearticle by Gassler et al. entitled “Transmyocardial LaesrRevascularization. Historical Features In Human Nonresponder Myocardium”appearing in Circulation, 95(2): 371-375, Jan. 21, 1997.

[0016] In summary, there a number of potential mechanisms whichindividually or in combination may be responsible for the improvementsseen in patients subjected to the previously described myocardialrevascularization techniques including: (1) new blood flow throughcreated channels, (2) angiogenesis (stimulation of the creation of newblood vessels), (3) cardiac denervation, (4) the placebo effect, and (5)ablation of ischemic myocardium.

[0017] Currently it is believed that cardiac denervation andangiogenesis are the primary causes for post procedure angina relief andimproved perfusion respectively. The injury stimulates vasculargenesisand the laser energy damages nerves thereby minimizing the painsensation. The lasers are however very expensive to purchase.

[0018] While the aforementioned techniques and methods forrevascularizing the myocardium offer some promise they never the lesssuffer from one disadvantage or another.

OBJECTS OF THE INVENTION

[0019] Accordingly, it is a general object of this invention to providea transmyocardial revascularization system which overcomes thedisadvantages of the prior art.

[0020] It is a further object of this invention to provide a system andmethodology for providing relief from ischemic myocardium.

[0021] It is a further object of this invention to provide apparatus andmethods for providing myocardial perfusion that reduce the level ofischemia in a patient.

[0022] It is a further object of this invention to provide methods andapparatus for myocardial revascularization to reduce the level ofdiscomfort associated with angina in a patient.

[0023] It is a further object of this invention to provide a device andmethod to enable patients that suffer from the later stages of ischemicheart disease to experience reduced pain and improved emotionalwell-being.

[0024] It is a further object of this invention to provide atransmyocardial revascularization system and methodology which is simpleand cost effective.

[0025] It is a further object of this invention to provide an apparatusand method for myocardial revascularization to increase blood flow tothe myocardium from the endocardium without using the native diseasedcoronary arteries.

[0026] It is a further object of this invention to provide an apparatusand method for myocardial revascularization to be used with patientshaving extensive coronary atherosclerosis in whom a bypass surgery isnot indicated.

[0027] It is a further object of this invention is to provide a deviceand technique for endovascular myocardial revascularization.

[0028] It is another object of the present invention to provide methodsand apparatus which can be utilized either in open surgical, minimallyinvasive surgical, or transluminal techniques to perfuse the myocardium.

[0029] It is a further object of this invention to provide directmyocardial revascularization without the need for opening the chestcavity.

[0030] It is a further object of this invention to provide directendovascular myocardial revascularization without having to utilize alaser (although a laser may be used, if desired in some applications aspart of the procedure).

SUMMARY OF THE INVENTION

[0031] These and other objects of this invention are achieved byproviding a cardiac vascularization system and methods ofrevascularizing the myocardium. The system basically comprises at leastone, and preferably a plurality of elongated small diameter inserts forintroduction at spaced locations from one another in the wall of themyocardium. The inserts are formed of a material to elicit a foreignbody or healing response to cause the formation of lumens incommunication with the arterial system. The inserts may be totallyresorbable, partially resorbable or non-resorbable, and in the case ofthe latter may be removable from the myocardium after the formation ofthe lumens.

[0032] In accordance with various preferred embodiments of the inventionthe system also includes various deployment instruments for deployingthe inserts into the wall of the myocardium. Some instrument arearranged to introduce the inserts into the myocardium via either thepericardium, while other instruments are arranged to introduce theinserts into the myocardium via the endocardium.

[0033] The deployment instruments may be configured to form the lumensbuy mechanical action or by the application of energy, e.g., electrical,thermal, sonic, radiation, etc., or some biological agent to themyocardium. The inserts themselves or in combination with the deploymentinstrument can be used to form the lumens.

[0034] In accordance with one aspect of the invention the system mayinclude means to stabilize the deployment instrument during theformation and/or insertion of the inserts into the myocardium. Inaddition control means may be provided to coordinate the operation ofthe deployment instrument with the cardiac cycle.

DESCRIPTION OF THE DRAWING

[0035] Other objects and many attendant features of this invention willbecome readily appreciated as the same becomes better understood byreference to the following detailed description when considered inconnection with the accompanying drawing wherein:

[0036]FIG. 1 is an illustration of the heart of a living human beingshowing one embodiment of a deployment instrument forming a portion ofthe myocardial revascularization system of the subject invention beingused to deploy plural inserts constructed in accordance with thisinvention into the myocardium via the pericardium;

[0037]FIG. 2 is an illustration similar to that of FIG. 1, but showinganother embodiment of a deployment instrument forming a portion of themyocardial revascularization system of the subject invention being usedto deploy those inserts into the myocardium via the epicardium;

[0038]FIG. 3 is an enlarged illustration of the heart of a living humanbeing showing the inserts of the system of FIG. 1 in place fullyembedded in the wall of the myocardium;

[0039]FIG. 4 is a side elevational view, partially in section, of analternative embodiment of an insert and an alternative deploymentinstrument forming an alternative embodiment of a system constructed inaccordance with this invention;

[0040]FIG. 5 is a side elevational view, partially in section, showinganother portion of the deployment instrument of the embodiment of thesystem shown in FIG. 4;

[0041]FIG. 6 is a side elevational view, partially in section, showingthe deployment of the insert of FIG. 4 into the wall of the myocardiumby the deployment instrument of FIGS. 4 and 5;

[0042]FIG. 7 is a side elevational view, partially in section, showingthe insert of FIGS. 4-6 when fully deployed in the wall of themyocardium;

[0043]FIG. 8 is an enlarged isometric view of the distal end of theinsert shown in FIGS. 4-7;

[0044] FIGS. 9A-9S are each isometric views of respective alternativeembodiments of inserts constructed in accordance with this invention;

[0045]FIG. 10A-10D are each side elevational view, partially in section,of various exemplary inserts of the subject invention shown in placewithin the wall of the myocardium;

[0046]FIG. 11 is a block and schematic diagram showing one embodiment ofthe system of the subject invention and including means to control theoperation thereof in accordance with the cardiac cycle;

[0047]FIG. 12 is a diagram like that of FIG. 11 but showing the additionof a mechanism, e.g., a vacuum hood, for use with a deploymentinstrument of this invention to stabilize the deployment instrument withrespect to the myocardium;

[0048]FIG. 13 is an illustration of a portion of the wall of a healthyheart showing its vascularity;

[0049]FIG. 14 is an illustration, like that of FIG. 13, but showing awall whose vasculature has been reduced over time by atherosclerosis,e.g., the branches of its coronary arteries are fully or partiallyoccluded and many of the capillaries in the myocardium have atrophied;

[0050]FIG. 15 is an illustration, like that of FIG. 14, but showing thewall of the heart immediately after deployment of an insert of thesystem of this invention in the myocardium to increase the flow of bloodfrom the ventricle via the lumen in which the insert is located totissue and capillaries contiguous with the lumen;

[0051]FIG. 16 is an illustration, like that of FIG. 15, but showing thewall of the heart some time after the deployment of an insert so thatthe insert has elicited a foreign body response in the myocardium tissueto stimulate angiogenesis and revascularization, whereupon the increasedflow of blood in one portion of a vessel can provide added blood toneighboring tissues and capillaries; and

[0052]FIG. 17 is an illustration, like that of FIG. 16, but showing thewall of the heart at some later time (i.e., after the insert has beenabsorbed or has been removed from its lumen), whereupon the lumen mayshrink in diameter but may remain patent to carry blood to contiguoustissue and capillaries, including the recently grown vasculature, tothereby provides a beneficial blood supply to the myocardium.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0053] Referring now to the drawing where like reference numerals referto like parts there is shown in FIG. 1 a transmyocardialrevascularization system 20 constructed in accordance with thisinvention shown in the process of revascularizing the myocardium of aliving, e.g., human, being. In FIG. 13 there is shown, by way of anillustration (not to scale), a section of the wall of the left ventricleof a healthy human heart 1. As can be seen therein the wall includes theepicardium 2, the myocardium 3, the endocardium 4, two unoccludedbranches 5 and 6 of a coronary artery and extensive associatedvasculature, e.g., capillaries 7. In FIG. 14 the illustration is of thesame portion of the wall of the ventricle, but showing the effects ofatherosclerosis, i.e., lesions or plaque deposits 8, in the branchvessels 5 and 6 and atrophied vasculature 7.

[0054] The revascularization systems of this invention are particularlysuitable for revascularizing the myocardium whose blood supply has beendiminished by atherosclerosis (like that shown in FIG. 14) or by otherdisease processes. Moreover. the subject invention contemplates variousdifferent systems and preferred ones of those systems will be describedin detail later. Suffice it for now to state that each systemconstructed in accordance with this invention includes at least one, andpreferably, a plurality of elongated inserts 22 (designated by thegeneral reference number 22 in FIG. 1) and a deployment instrument(e.g., instrument 24 of FIG. 1) for deploying the insert(s) into themyocardium. Various alternative inserts 22A-22S are shown in FIGS.9A-9S, respectively.

[0055] In accordance with one preferred embodiment of a system thedeployment instrument 24 utilizes a piercing member (to be describedlater) located adjacent its distal end to create plural channels orlumens 9 (FIGS. 1 and 15) in the wall of the myocardium 3 at spacedlocations from one another and into which respective inserts (e.g.,inserts 22 of FIG. 1) are deployed. Other means can be utilized to formthe channels or lumens 9. For example the system may include means,e.g., as part of the deployment instrument or some other device, forproviding a suitable biological agent to the myocardium and associatedtissue (e.g., endocardium or epicardium) to produce or form a lumen inthe myocardium. Alternatively, the deployment instrument can provide oneor more of various types of energy to that tissue to create the lumen(s)and then the insert(s) can be deployed therein. Examples of varioustypes of energy contemplated for such a procedure are thermal energy,mechanical energy (e.g., rotational cutting or boring, slicing, etc),electrical energy (e.g., radio frequency energy), hydraulic energy,pneumatic energy, vibratory energy (e.g., sonic, ultrasonic, etc.)radiation energy, laser or other light energy, or other types ofelectromagnetic energy, etc. It should be pointed out at this juncturethat the application of energy to the cardiac tissue not only serves tocreate the lumen(s) 9 for the insert(s) 22 and 22A-22S, but can alsodisable local nerves (denervation) to minimize patient pain resultingfrom angina.

[0056] It should also be pointed out that the formation of the channelsor lumens 9 in the myocardium and associated tissue can be accomplishedby means other than the insert-deployment instrument 24. In this regardthe subject invention contemplates that the inserts themselves can beconstructed so that they can be used to pierce or otherwise penetrateinto the wall of the myocardium to form the lumens. In such applicationsthe formation of the lumens is accomplished at the same time that theinserts are deployed therein.

[0057] Irrespective of how the lumens 9 are formed, the inserts can beinserted into the wall of the myocardium 3 and into the lumens (or toform the lumens), via either a transthoracic approach to the epicardium2 (see FIG. 1) or by a percutaneous transvascular, e.g., transfemoral,approach to the endocardium 4 (see FIG. 2). When the lumens are formedby transthoracic approach they are preferably made sufficiently deep tocommunicate with the interior of the ventricle. However, for some typeof myocardial revascularization procedures communication of the lumenwith the ventricular chamber is not necessary, as will be describedlater.

[0058] When the lumen(s) is(are) in communication with the ventricularchamber and the insert(s) is(are) in place within those lumens, theinsert(s) serve(s) to hold the lumen(s) open and allow blood to flowinto the lumen(s) from the ventricular chamber, whereupon that blood cannourish tissue and capillaries in the myocardium contiguous with thelumen.

[0059] In accordance with a preferred aspect of this invention, theinserts are formed of a material so that when they are in place theyserve to initiate a “foreign body” or “healing response” in the local(i.e., contiguous) tissue, whereupon the inserts can be removed orabsorbed thereafter, leaving the lumens patent to supply blood tocontiguous tissue, capillaries and additional vasculature (e.g., newcapillaries) which have grown over time by virtue of the process ofangiogenesis. This action ensures that the myocardium receives anincreased blood supply over that which it received prior to the subjecttransmyocarial revascularization (TMR) procedure.

[0060] Even where the lumen(s) formed do not communicate with theinterior of the ventricular chamber, its (their) formation and thedeployment of the insert(s) therein still has an advantageous effectinsofar as providing beneficial blood flow to the myocardium isconcerned. In this regard the formation of a lumen and the deployment ofan insert therein serves to bridge those capillaries which arecontiguous with the lumen. Thus, blood can be carried from capillariesin one portion of the myocardium to capillaries in a remote portionthereof by the lumen bridging those capillaries. In addition, over timethe healing response and resultant angiogenesis induced by the presenceof the inserts in the lumen will increase the myocardial vasculature,thereby further benefiting the patient.

[0061] In some applications it may be desirable to stabilize thedeployment instrument against the endocardium or epicardium during therevascularization procedure. For such applications the system makes useof some releasable securement or attachment means, such as a suctionhood (to be described later) to stabilize or otherwise hold thedeployment instrument in place. Once positioned, the instrument can beactivated to advance the piercing member or to direct energy into thecardiac tissue to create the lumen and to introduce an insert therein.

[0062] In some applications, depth control means (also to be describedlater) may be provided to limit the depth of penetration of theinsert(s) into the myocardium. The depth control means may comprisemeans to limit the depth of the lumen(s) created by the instrument, ormay comprise means on the insert itself to limit its depth ofpenetration into the lumen or may be a combination of both.

[0063] In some applications, e.g., where the deployment instrumentapplies electrical energy to the cardiac tissue to form the lumen(s) orwhere formation of the lumen(s) and/or deployment of the insert(s)therein is best accomplished during a particular portion of the cardiaccycle, the system may also include some control and sensing means (alsoto be described later) that synchronizes the operation of the deploymentinstrument to a specific portion of the cardiac cycle.

[0064] As will also be described later, the inserts 22 and 22A-22R areof various shapes, e.g., solid, tubular, trough-like, helical(spring-shaped), filament, or ribbon-like members, etc. They may be ofany suitable biocompatible material, and may be formed of one or moreresorbable materials so as to be either partially or totally resorbable.Examples of suitable resorbable materials are polyglycolic acid,polydiaxonone, polycaprolactone, collagen, hyaluronic acid, a polymercomposite and/or oxidized regenerated cellulose.

[0065] Referring again to FIG. 1 the details of the system 20 as showntherein will now be discussed. As mentioned earlier that systemcomprises a deployment instrument 24 and plural inserts 22. Theinstrument 24 itself basically comprises an elongated central wire 26having pointed or otherwise sharp distal end or piercing tip 28. Aflange 30 projects outward from the periphery of the wire 26 a shortdistance proximally of the tip 28. The insert 22 is a tubular memberwhich is arranged to be disposed and frictionally held on the wire 28between the flange 30 and the tip 28 so that it can be carried by thewire 26 into the epicardium and underlying myocardium by the applicationof a force in the distal direction on the wire. In this regard theproximal end (not shown) of the wire 28 is coupled to means (also notshown) arranged to have a pushing force applied thereto by either manualaction or by some component, e.g., a motor or other actuator, undercontrol of a control system 52, like that shown in FIG. 11. This pushingaction causes the tip 28 of the wire 26 to pierce through the epicardiumand underlying myocardium to form a lumen 9 with further advancement ofthe wire 26 in the distal direction carrying the insert into the lumen9.

[0066] As mentioned above, the embodiment of the insert shown in FIG. 1and designated by the reference number 22 basically comprises a smalldiameter, elongated tubular member. That member is similar to the insertshown in FIG. 9A, and as best seen therein has a central channel orpassageway 32 through which the wire 26 may pass when the insert ismounted thereon. The insert also includes plural apertures 34 in thewall forming it and which are in fluid communication with the passageway32, for the reasons to be described later. An optional flange may beprovided about the periphery at the proximal end 36 of the tubularinsert as shown in FIG. 9A. The flange serves as a stop to engagecardiac tissue to preclude the insert from being inserted too deep intothe myocardium. Insert 22 does not include the flange. The distal end 38of insert 22 is open and is in communication with the passageway 32.

[0067] The insert 22 may be formed of any of the aforementionedresorbable materials so that it will be absorbed over time leaving alumen 9 like that shown in FIG. 17. Alternatively it may be formed of anon-resorbable material. In that case it may be preferable that theinsert be removable after some time to leave a lumen 9 like shown inFIG. 17.

[0068] When the insert 22 is located on the deployment instrument's wire26 its proximal end 36 (FIG. 9) is in abutment with the flange 30 on thewire and with the piercing tip 28 of the wire extending out of thedistal end 38 of the insert as shown in FIG. 1. As mentioned above, theproximal end of the wire 26 is coupled to means to have a pushing forceapplied thereto manually or under control of a control system 52 likethat shown in FIGS. 11 or 12. This pushing action causes the tip 28 ofthe wire 26 to pierce through the epicardium and underlying myocardiumto start to form a lumen 9. At the same time the flange 30 on the wireabuts the proximal end 36 of the insert to push the insert along with itto carry the insert into the lumen 9 as it is formed. The stop on theinsert (if incorporated into the insert) or the flange 30 of the wire 26is arranged to enable the proximal end of the insert to pass through theepicardium and just slightly into the underlying myocardium and with thelength of the insert 22 being selected so that the open distal end 38 ofthe insert just enters the ventricle. To that end, the length of theinsert is preferably selected to be consistent with the thickness of themyocardium into which it is implanted. In order to accommodate variousthicknesses of myocardia, the inserts of the subject invention may bepre-cut to any length in the range of approximately 0.6 cm to 2.0 cm inlength. Moreover, for typical application the inserts preferably have anoutside diameter in the range of approximately 1.5 mm to 2.5 mm and aninside diameter in the range of approximately 1.0 to 2.0 mm.

[0069] In order to stabilize the deployment instrument 24 during thelumen forming-insert deployment procedure, the device 24 of the systemmay be constructed like shown in FIGS. 1 and 12 to include a releasablysecurable attachment mechanism in the form of a suction hood 40 andassociated components. The suction hood 40 basically comprises anelongate tube 42 having a central passageway 44 for accommodating theinsert deployment wire 26 with the insert 22 mounted on the distal endthereof. An enlarged flange 46 extends about the periphery of the distalend of the tube 42 for engagement with the epicardium. A source ofvacuum 48 (FIG. 12) is coupled to the proximal end of the tube 42. Thevacuum source is arranged to be actuated by operation of the operatorcontrol 50 (FIG. 12). This action couples the vacuum source 48 to theinterior of the tube 42 to produce suction at the distal end of the hoodto hold the hood in place on the pericardium centered over the locationat which an insert is to be deployed. The operator control 50 can thenbe activated to cause the control system 52 and its various componentsto operate to effect the pushing of the deployment instrument's wire 26(with the insert 22 mounted thereon) distally into the epicardium andunderlying myocardium, as discussed above.

[0070] If it is desired to time the introduction of the insert 22 intothe myocardium to any particular portion of the cardiac cycle, e.g.,during diastole, then the system may include use of a cardiac cyclemonitor 54 and an associated cardiac sensor 56. The cardiac sensor 56can be any suitable conventional device for providing an electricalsignal indicative of the cardiac cycle. The cardiac cycle monitor isresponsive to the sensor for providing signals to the control system 52,which controls the operation of the deployment instrument incoordination with the sensed cardiac cycle. Thus, the control systeminitiates the operation of means in the system coupled to the wire 26 topush the wire distally at a predetermined point in the cardiac cycle.

[0071] After each of the inserts 22 has been deployed into themyocardium, the instrument is removed, i.e., the wire 26 extracted, andthe insert 22 left in place. Thus, since the distal end 38 of the insert22 is open and in fluid communication with the interior of the leftventricle blood from the left ventricular chamber can flow into thedistal end of the insert and be carried down its central passageway 32and out through the apertures 34 into the adjacent myocardial tissue andcapillaries. Since the proximal end of the insert is preferably locatedjust under the epicardium, when the insertion wire 26 is withdrawn thepuncture in the epicardium through which the insertion wire passed willclose off and hemostasis will occur shortly thereafter. This action willprevent the leakage of blood out of the lumen 9 through the epicardium.

[0072] As will be appreciated by those skilled in the art the shape ofthe insert 22 (as well as all of the other inserts of this invention)will keep the lumen 9 in which it is located open to the flow of bloodtherethrough. Over time the body's natural healing response to the“foreign” insert deployed within the lumen 9 will result in increasedvasculature contiguous with the lumen, like shown in FIG. 17. It shouldbe noted that in FIG. 17 the relevant cardiac portion is shown after theinsert has either been absorbed or removed, but the result is the same,namely, the formation of new capillaries and vessels as a result of thebody's natural healing response and angiogenesis caused by the one-timepresence of the insert within the lumen.

[0073] In FIGS. 15-17 the revascularization of the myocardium of anatherosclerotic diseased heart is illustrated. In particular, in FIG. 16there is shown the same portion of the heart shown in FIG. 14, anddescribed earlier, but after a lumen 9 has been formed in the myocardiumand an alternative embodiment of an insert located within that lumen.The alternative insert is the embodiment of the insert shown in FIG. 9Mand designated by the reference number 22M. The details of this insertwill be described later. Suffice it for now to state that insert 22M isin the form of a cylindrical coil or helix and has been inserted a lumen9 formed in the same manner as described earlier. Since the insert 22Mis a helix, it will hold the lumen 9 open and in communication with theinterior of the ventricle at its distal end. Moreover, blood can flowinto the lumen through the center of the insert 22M and out through thespaces between contiguous coils to feed the contiguous myocardial tissueand capillaries. On the short term any capillaries which receive bloodfrom the lumen 9 can carry that blood to remote locations, therebynourishing the tissue at such remote locations by the delivery of moreblood thereto than prior to the procedure. Over time the body's naturalhealing response and angiogenesis will result in increased vasculature,such as shown in FIG. 16.

[0074]FIG. 17 shows the condition after angiogenesis has occurred tocreate significant new vasculature, e.g., capillaries 7, and the insert22 either has been removed or resorbed by the body. The resorption orremoval of the insert from the lumen, so that the insert is no longerpresent to hold the lumen open, may permit the lumen to shrink orotherwise decrease somewhat in diameter, as illustrated in FIG. 17, oreventually close. Even if the lumen 9 eventually closes there will stillbe some beneficial effect since the tissue contiguous with the lumen 9will be more highly vascularized than prior to the insertion of theinsert due to the elicited angiogenesis.

[0075] As should be appreciated from the foregoing whether the system 20makes use of nonresorbable or resorbable inserts is of little relevancefrom the standpoint of immediately increased blood flow to themyocardium tissue and capillaries contiguous with the lumens so long asthe inserts are constructed to enable blood to flow therethrough ortherearound in the lumens from the interior of the ventricular chamber.If, however, the inserts are constructed so that they do not allow bloodto flow therethrough or therearound within the lumens, then thebeneficial effects, e.g., increased vasculative, of the inserts will notlikely arise until after they have induced the natural healing responsein the myocardium and have been absorbed or otherwise removed from themyocardium.

[0076] It should be pointed out at this juncture that for someapplications the inserts may be constructed so that they do not extendinto communication with the ventricular chamber to permit blood to flowfrom the ventricle into the lumen. One such alternative arrangement isshown in FIG. 3. In that illustration the inserts 22 are shown as beingfully located (embedded) within the myocardium. Since there will be noblood flow into the lumens from the ventricular chamber, thisarrangement will not serve to immediately increase the amount of bloodavailable to the myocardium tissue in which the inserts 22 are located.However, if the inserts are constructed so that blood can flow eitherthrough them (e.g., they include a longitudinal passageway and sidewallapertures like those described earlier, or are porous, etc.) or aroundthem within the lumen, then blood from tissue and/or capillariescontiguous with one portion of the lumen 9 can be carried to otherportions of the lumen and the tissue and capillaries contiguoustherewith. Thus, the presence of the inserts in the lumens may serve tobring blood from one portion of the myocardium to other portions.Moreover, the angiogenesis action resulting by the location of theinserts within the lumens over time will further revascularize themyocardium.

[0077] In FIG. 2, a system 100 constructed in accordance with thisinvention is shown during the process of revascularizing the myocardiumvia a transvascular access to the endocardium and myocardium. The system100 comprises a small diameter, flexible deployment instrument 102 andone or more inserts constructed like those described heretofore. Inparticular, in the example shown in FIG. 2, the inserts used are theinserts 22. The instrument 102 comprises an outer tube or catheter 104,an inner tube 106, and a flexible wire 108. The wire 108 has a pointeddistal end or piercing tip 110. The catheter 104 includes a centralpassageway 112 extending down its length and terminating at a free endin the form of a rounded or non-sharp tip 114. The inner tube 106 isdisposed within the passageway 112 and is movable longitudinally withrespect to the catheter 104. The inner tube 106 includes a centralpassageway through which the wire 108 extends, with the tip 110 of thewire extending beyond the free end 116 of the inner tube by a distancejust slightly greater than the length of an insert 22.

[0078] The insert 22 is located on the extending portion of the wire 108as shown in FIG. 2. When introduced through the vascular system and intothe heart the inner tube 106 and wire 108 are fully retracted within thecatheter 104 but located adjacent its tip 114. The rounded tip 114 ofthe catheter serves as the end of the instrument 102 to facilitate itssafe guidance to the operative position shown in FIG. 2. At that timethe inner (pusher) tube 106 with the wire 108 extending therethrough ispushed distally by some means, e.g., manually or by some activatorforming a portion of the control system 52, so that the wire's tip 110penetrates through the endocardium and into the myocardium. Thecontinued pushing action forms the lumen and carries the insert into thelumen 9 in a similar manner as described earlier. When the insert is inthe desired position within the myocardium the wire 108 is retractedwith respect to the inner tube 106 until it no longer is within theinsert, thereby depositing the insert within the lumen 9. The instrumentcan then be used to deploy other inserts 22 in the same manner, and onceall have been deployed the instrument is retracted as a unit from theheart and out of the associated vascular access path.

[0079] In FIGS. 4-8 there is shown another alternative system 200 (FIG.5) for effecting the revascularization of the myocardium. The system 200is of manual type and basically comprises at least one insert 22R, likethat shown in FIG. 9R, and a manually operated deployment instrument 202for deploying the insert in a lumen in the myocardium. The insert 22Rbasically comprises a resorbable suture 204 or other flexible filamenthaving a distal end at which a barbed resorbable anchor 206 is fixedlysecured. The anchor includes a rounded distal end 208 (FIG. 8) fromwhich plural fingers 210 project backward. The fingers may be somewhatflexible to facilitate the disposition of the insert within theinstrument 202 (as will be described later).

[0080] The instrument 202 basically comprises a pusher member 212 and apiercer member 214. The pusher member 212 is in the form of a smalldiameter tube having a tapered distal end 216, a flanged proximal end218 forming a cap, and a central passageway 220 extending therebetween.The suture or filament portion 204 of the insert 22R is located withinthe passageway 220, with the anchor 206 being located immediatelydistally of the tapered distal end 216 of the pusher as shown in FIG. 4.

[0081] The piercer member is a small diameter tube having a bias-cutdistal end to form a piercing tip 224, a flanged proximal end forming ahandle 226, and a central passageway 228 extending therebetween. Theentrance to the passageway 228 is flared at 230. The inside diameter ofthe passageway 228 is slightly greater than the outside diameter of thepusher member 204 so that the pusher member can be located therein, withthe fingers 210 of the anchor position 206 of the insert 22R flexedradially inward to enable the anchor to fit within the passageway 228 asshown in FIG. 5.

[0082] The instrument 202 is particularly suitable for transthoracicintroduction into the myocardium 3. To that end the instrument 202 isassembled as shown in FIG. 5 and manipulated (i.e., pushed distally)such that the needle's piercing tip 224 pierces the epicardium 2 andenters to a desired depth into the myocardium 3 to form a lumen 9. Asshown in FIG. 6 the depth of penetration is less than the thickness ofthe myocardium so that the lumen 9 is not in communication with theinterior of the ventricular chamber (although it could extend therein,if desired). Stop means (not shown) forming a portion of the instrument202 can be provided to establish the desired depth of cardiacpenetration.

[0083] Once the piercer member is at the desired depth, the cap 218 ofthe pusher member is pushed distally with respect to piercer member'shandle 226 to extend the insert's anchor 206 into the lumen tract,whereupon the freeing of the anchor's fingers 210 allows them to flexoutwardly as shown in FIG. 6. The pusher member 212 and the piercermember 214 are then withdrawn as a unit proximally, so that the filamentportion 204 is freed leaving the insert in place like shown in FIG. 7.The anchor of the insert serves to secure it within the lumen 9resistant to accidental dislodgment during the deployment procedure. Itshould be pointed out that the anchor can take various forms, e.g., be arigid barb-like member lacerated on the outer portion of the insert orit can be an activatable pivoting member (not shown) similar inconstruction to that used on a conventional clothing label tag, or anyother suitable construction.

[0084] The filament portion 204 may consist of a solid filament, such asa PGA suture, or a strip of material, such as collagen or Gelfoam, ormay be non-resorbable, like Gortex. In any case the material for thefilament portion 204 is selected to initiate a foreign body reaction tostimulate arteriogenesis in a manner similar to that described earlier.

[0085] It must be pointed out at this juncture that each insert of thisinvention is preferably configured such that its presence in themyocardial tissue does not significantly limit the contractility of thecardiac muscle, although as will be described later some embodimentsprovide less resistance to cardiac contractility than others. Moreover,the inserts may be coated with or contain growth factors, anti-oxidants,seeded cells, or other drug/biologically active components dependingupon the result desired.

[0086] Referring now to FIGS. 9A to 9S, the details of other insertsconstructed in accordance with this invention will be described. Theseinserts are merely exemplary of many other inserts which can beconstructed to accomplish the ends of this invention.

[0087] The embodiment of the insert 22A shown in FIG. 9A is a tubularstructure with axial perforations 34 for allowing blood to pass throughthe longitudinal passageway 32 and to pass through the lateralperforations 34 into the adjacent myocardium.

[0088] The embodiment of the insert 22B shown in FIG. 9B is atrough-like structure 60 with slots 62 in the marginal edges to formfins for holding the lumen 9 open. The slots 62 allow more contact ofthe blood to the neighboring myocardium. The tip 64 is sharpened tofacilitate the deployment, e.g., it helps pierce the cardiac tissueduring deployment.

[0089] The embodiment of the insert 22C shown in FIG. 9C is a simpletrough-like structure 66, that is relatively easy to manufacture, e.g.,can be made by die cutting a rectangular sheet and forming the sheetaround a pin.

[0090] The embodiment of the insert 22D shown in FIG. 9D comprises aporous walled tube 68, with a longitudinal passage 70 extending down itscenter and whose distal end 72 is open.

[0091] The embodiment of the insert 22E shown in FIG. 9E is a series oftubular cylindrical sections 74 that are connected by flexible filaments76. This structure effectively stents the lumen opening and allows theinsert to freely contract and expand along the longitudinal axis andtherefore conform to the contraction of the myocardium during thecardiac cycle.

[0092] The embodiment of the insert 22F shown in FIG. 9F is formed ofseveral spherical beads 78 spaced on a flexible filament 76. Thefilament also incorporates a T-shaped distal end in the form of anchormember 82 to aid in placement or securement. This insert alsoeffectively stents the lumen and allows the insert to freely contractand expand along the longitudinal axis and therefore conform to thecontraction of the myocardium during the cardiac cycle.

[0093] The embodiment of the insert 22G shown in FIG. 9G is similar tothat shown in FIG. 9F except that the periodically spaced barbstructures 82 extend outward from the filament 80 at spaced locations.This arrangement may better anchor the insert in the myocardium and mayalso allow for better fluid communication past each barb structure alongthe length of the lumen 9 than the embodiment 22F of FIG. 9F.

[0094] The embodiment of the insert 22H shown in FIG. 9H is acylindrical porous material tube 68 with a proximal end in the form of ashoulder 84 to limit penetration. This particular embodiment appearsbest suited for insertion from the endocardium into the myocardium,whereupon the shoulder 84 anchors the opening of the insert at theventricle.

[0095] The embodiment of the insert 221 in FIG. 9I is a flexible woventube 86 having plural equidistantly spaced reinforcing rings 88. Thewoven portions of the tube are porous to allow blood to pass from theinner passageway 90 for communication with the blood vessels andcapillaries contiguous with the other lumen 9. The reinforcing rings 88support the insert and the adjacent myocardium to keep the lumen fromcollapsing.

[0096] The embodiments of the inserts 22J, 22K, and 22L shown in FIGS.9J, 9K and 9L, respectively, consist of flexible ribbon-like structures22 with anchors 94, 96, and 98, respectively, on the distal end forlocating and securing the inserts into the myocardium. The ribbon-likematerial can be formed of materials such as woven dacron, polyglycolicacid, cotton, silk, and collagen. The ribbon-like tail of theseembodiments can be made extra long and after implantation during asurgical approach whatever portion extends from the epicardium can betrimmed off (see FIG. 10B). The anchor portion can be formed by insertmolding the anchor component onto the filament structure. The mainfeature of these constructions is to stimulate a foreign body reactionand a healing response which results in the formation of capillaries atthe site of the implant. As such, these structures will provide less ofa short term improvement to vascularization, but instead will lead to along term improvement.

[0097] The embodiment of the inserts 22M, 22N, and 22O shown in FIGS.9M, 9N, and 9O, respectively, consists of helical coil-like structures120. The implants can be formed of such materials as stainless steel,nitinol, titanium or such material as polyglycolic acid or polylacticacid. The embodiments are flexible, particularly with respect to theirlongitudinal axis and as such will readily deform longitudinally inconjunction with the cardiac cycle of the myocardium. These structuresserve to stent the lumen 9 and allow for excellent fluid communicationbetween the lumen 9 and the adjacent blood vessels. The embodimentsshown in 9N and 9O have anchoring portions at their respective distalends which can be used to locate and secure the inserts in themyocardium. In particular, the insert 22N includes a hook-like member122 at its distal end, whereas the insert 22O includes a plate-likeanchor 124 at its distal end.

[0098] The embodiment of the insert 22P shown in FIG. 9P is a flexiblefilament-like member 126 with a stiffened distal end portion bent backover itself for anchoring the insert into the myocardium. This insertfunctions in a similar manner to the inserts of embodiments 22J, 22K and22L.

[0099] The embodiment of the insert 22Q shown in FIG. 9Q is a perforatedcylinder member, similar to insert 22A but with tongue-like member 130at the proximal end of the cylinder to form a shoulder. The shoulderserves to limit the depth of placement of the insert into themyocardium. This particular embodiment is particularly suited to beingplaced through the epicardium into the myocardium. The bulbous portionof the shoulder limits the depth of penetration into the myocardium andthe epicardium seals around it to prohibit leakage from the channel pastthe epicardium like shown in FIG. 10D.

[0100] The embodiment of the insert 22R shown in FIG. 9R has beendescribed earlier. This insert 22R functions in a similar manner toinserts 22J, 22K and 22L. Moreover, the filament-like tails of theseembodiments can be made extra long to be trimmed off in a similar mannerto that described earlier with reference to inserts 22J, 22K and 22L.The filament can be formed of Dacron, polyester, silk, polyglycolicacid, collagen, or some other such suitable material. The main featureof these constructions is to stimulate a foreign body reaction and ahealing response which results in the formation of capillaries at thesite of the implant. As such, these structure will provide less of ashort term improvement to vascularization, but instead will lead to along term improvement.

[0101] The embodiment of the insert 22S shown in FIG. 9S is a “flowable”insert comprised of a flowable material 132, such as collagen paste,cyanoacrylate (glue/adhesive), thrombin glue, growth factor gelatin,etc. The flowable material can be stored in a tube (not shown) anddispensed into the puncture tract by a needle-like device, such as asyringe (not shown). The flowable material can be designed to hardenslightly after placement, like an epoxy or silicon caulking material, sothat it is not extruded from the puncture during the cardiac contractioncycle. A main feature of this construction is to stimulate a foreignbody reaction and a healing response which results in the formation ofcapillaries at the site of the implant. As such, the insert 22S willprovide less of a short term improvement to vascularization, but insteadwill lead to a long term improvement.

[0102] In FIGS. 10A to 10D various of the inserts described above areshown in place in the myocardium to cause the body to initiate a healingresponse in tissue contiguous with the lumen, as described heretofore.The tissue at which the foreign healing response occurs at initially isdesignated by the reference number 11 in those figures. While not shownin FIGS. 10A-10D, additional or new vasculature results in themyocardial tissue as a result of angiogenesis Without furtherelaboration the foregoing will so fully illustrate our invention thatothers may, by applying current or future knowledge, adopt the same foruse under various conditions of service.

What is claimed is:
 1. A system for vascularizing the myocardium and/orassociated tissue of a living being to produce at least one lumen incommunication with the being's arterial system, said system comprising aplurality of inserts and a delivery system, said inserts comprising aflowable agent, said delivery system comprising channel producing meansarranged for creating at least one channel in the myocardium and/orassociated tissue, said delivery system arranged to deposit saidflowable agent into the at least one channel.
 2. The system of claim 1wherein said at least one lumen is a new blood carrying vessel andwherein said flowable agent deposited in the at least one channel isoperative to produce the new blood carrying vessel.
 3. The system ofclaim 2 wherein said flowable agent serves to elicit a foreign body orhealing response in said myocardium and/or associated tissue.
 4. Thesystem of claim 1 wherein at least a portion of said flowable agent isselected from the group consisting of one or more of drugs,pharmaceuticals, biologically active materials, growth factors,radiopaque materials, antioxidants, and seeded cells.
 5. The system ofclaim 1 wherein at least a portion of said flowable agent is at leastpartially resorbable.
 6. The system of claim 5 wherein said portion ofsaid flowable agent is fully resorbable.
 7. The system of claim 5wherein said portion of said flowable agent comprises polyglycolic acid,polydiaxonone, polycaprolactone, collagen, hyaluronic acid, oxidizedregenerated cellulose, or polymer composites.
 8. The system of claim 6wherein said portion of said flowable agent comprises polyglycolic acid,polydiaxonone, polycaprolactone, collagen, hyaluronic acid, oxidizedregenerated cellulose, or polymer composites.
 9. The system of claim 1wherein said channel producing means comprises piercing means.
 10. Thesystem of claim 9 wherein said piercing means comprises a mechanicalmeans.
 11. The system of claim 10 wherein said mechanical meanscomprises rotational cutting, boring, puncturing, or slicing.
 12. Thesystem of claim 9 wherein said piercing means comprises energyapplication means.
 13. The system of claim 12 wherein said energyapplication means provides energy selected from the group consisting ofone or more of electrical, thermal, electromagnetic, vibratory,hydraulic, pneumatic, and radiation.
 14. The system of claim 1 whereinsaid channel producing means is arranged for creating plural channels inthe myocardium and/or associated tissue and wherein said delivery systemarranged to deposit said flowable agent into the plural channels. 15.The system of claim 1 additionally comprising depth limitation means.16. The system of claim 1 additionally comprising stabilizing means. 17.The system of claim 1 additionally comprising controller means tocoordinate deployment of said flowable agent with the cardiac cycle. 18.The system of claim 15 wherein said depth limitation device comprises aflange.
 19. The system of claim 15 wherein said depth limitation devicecomprises a shoulder.
 20. The system of claim 15 wherein said depthlimitation device comprises a vacuum hood.
 21. The system of claim 16wherein said stabilizing means comprises a vacuum hood.
 22. The systemof claim 1 wherein said delivery system is arranged to introduce saidinserts via a transthoracic route.
 23. The system of claim 1 whereinsaid delivery system is arranged to introduce said inserts via apercutaneous transvascular route.
 24. The system of claim 1 wherein saiddelivery system further comprises denervation means.
 25. The system ofclaim 1 wherein said channel producing means comprises denervationmeans.
 26. The system of claim 1 wherein at least some portion of saidflowable agent is porous.
 27. The system of claim 1 wherein said channelproducing means comprises a biologically active substance.
 28. Thesystem of claim 1 wherein said flowable agent becomes less flowable withthe passing of time, so as to prevent extrusion from said channel.
 29. Amethod of revascularizing the myocardium and/or associated tissue of aliving being comprising: (a) providing at least one insert, said insertcomprising a flowable agent; (b) providing a delivery system, saiddelivery system comprising channel producing means; (c) utilizing saidchannel producing means to create at least one channels in themyocardium and/or associated tissue; and (d) introducing said flowableagent into said at least one channel.
 30. The method of claim 29 whereinsaid system creates plural channels in the myocardium and/or associatedtissue and wherein said flowable agent is introduced into each of saidchannels.
 31. The method of claim 29 wherein said introduction of saidflowable agent into said channel results in the formation of a new bloodcarrying vessel coupled to the being's arterial system.
 32. The methodof claim 31 wherein said flowable agent serves to elicit a foreign bodyor healing response in said myocardium and/or associated tissue.
 33. Themethod of claim 29 wherein at least a portion of said flowable agent isselected from the group consisting of one or more of drugs,pharmaceuticals, biologically active materials, growth factors,radiopaque materials, antioxidants, and seeded cells.
 34. The method ofclaim 29 wherein at least a portion of said flowable agent is at leastpartially resorbable.
 35. The method of claim 34 wherein said portion ofsaid flowable agent is fully resorbable.
 36. The method of claim 34wherein said portion of said at least one bead comprises polyglycolicacid, polydiaxonone, polycaprolactone, collagen, hyaluronic acid,oxidized regenerated cellulose, or polymer composites.
 37. The method ofclaim 35 wherein said portion of said at least one bead comprisespolyglycolic acid, polydiaxonone, polycaprolactone, collagen, hyaluronicacid, oxidized regenerated cellulose, or polymer composites.
 38. Themethod of claim 29 wherein said channel producing means delivers saidflowable agent into the myocardium and/or associated tissue to form saidat least one channel therein.
 39. The method of claim 38 wherein saidchannel producing means delivers said flowable agent into the myocardiumand/or associated tissue to form plural channels therein